Such a listing not only sets the groundwork for Medicare reimbursement of frontline Revlimid, but may ease the process of reimbursement from other insurers as well.

10.25.07

Drug compendia DRUGDEX and DrugPoints, used by the Centers for Medicaid and Medicare Services (CMS) as legally approved guidance documents regarding reimbursement for off-label uses of drugs (that is, for uses other than that defined by the FDA in their approval of the drug), have listed Revlimid in combination with dexamethasone as an off-label frontline therapy for myeloma. Currently, Revlimid has been FDA approved only for myeloma patients who have had at least one prior therapy. Drug compendia can list an off-label use for a drug if at least two clinical studies that demonstrate the efficacy of the drug in the as yet unapproved setting have been published. Such a listing not only sets the groundwork for Medicare reimbursement of frontline Revlimid, but may ease the process of reimbursement from other insurers as well.

Following is the listing in the DRUGDEX and Drug Point compendia for Revlimid in the frontline setting: